BCI-Controlled Robotic Exoskeleton for Stroke

Overseen By Lauren Souders, MOT, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurolutions, Inc.

Disqualifiers: Cognitive impairment, Contractures, Receptive aphasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a remote therapy that helps stroke patients move their hands using brain signals to control a robotic device. It targets patients with ongoing movement difficulties on one side of their body. The system works by detecting brain signals and moving a robotic hand to aid in motor skill improvement.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 who have had a stroke and now experience weakness or paralysis in one arm. They should not be receiving other upper extremity therapies, have severe cognitive impairments, contractures that prevent device use, certain communication difficulties, or conditions affecting pain sensation.

Inclusion Criteria

I have had a stroke.

I am not receiving Botox for my arm, or if I am, it's scheduled around the training start.

I have weakness or paralysis in one arm.

Exclusion Criteria

I can feel pain and do not have nerve or sensory issues that affect this.

You have trouble understanding and following written instructions or have a low score on a language test.

Participants who are pregnant or breast-feeding will be excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Remote EEG screening

Treatment

Participants receive either the IpsiHand BCI system or a standard home exercise program for 12 weeks

12 weeks

Daily virtual monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IpsiHand Device

Trial Overview The study compares the effectiveness of a home-based brain-computer interface therapy using the IpsiHand System against standard exercises for improving arm function after stroke. Participants will either use the BCI-controlled robotic hand exoskeleton at home or follow an exercise program.

How Is the Trial Designed?

Group I: Standard of Care - Home Exercise Program for Upper Extremity Experimental Treatment 1 Intervention

Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Once randomized, the participant will be assigned to group 2 to begin standard of care treatment at home. Phase 2: After being assigned to Group 2, subjects will serve as the control group in the study. Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks to control for the non-specific motor and sensory effects of BCI training. To help ensure compliance with the at-home portion of the protocol in the control group, participants will receive daily virtual monitoring from the study clinical specialist.

Group II: BCI treatment Group using the IpsiHand Experimental Treatment 1 Intervention

Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Subjects will undergo an EEG screening protocol to ensure that a consistent control signal will be present to control the IpsiHand device. After an EEG screening session is complete, the participants screening data will be analyzed to ensure that sufficient cortical signals are present. Randomization for assignment to group 1 or 2 will then occur. Once assigned to group 1, if consistent signals are found, the participant will then continue to Phase 2. Phase 2: Group 1 subjects will be provided with a Neurolutions IpsiHand BCI system, which combines a novel powered exoskeleton with a commercial EEG amplifier and active electrode system. The exoskeleton opens and closes the patient's hand in a three-finger pinch grip. Patients will use the BCI system on a minimum of 5 days per week for 12 weeks. Patients will complete five or more 10-minute runs of the BCI task per day.

Who Is Running the Clinical Trial?

Neurolutions, Inc.

Lead Sponsor

Trials

4

Recruited

160+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+